*Materials* **2018**, *11*, 1915

#### *2.3. Workplace*

Directive 89/654/EEC [15] lays down minimum requirements for safety and health at the workplace. For the purposes of this directive, 'workplace' means the place intended to house workstations on the premises of the undertaking and/or establishment and any other place within the area of the undertaking and/or establishment to which the worker has access in the course of his employment.

On the other hand, Directive Seveso III shall apply to establishments. Establishment means the whole location under the control of an operator where dangerous substances are present in one or more installations, including common or related infrastructures or activities; establishments are either lower-tier establishments or upper-tier establishments. Thus, establishments under Seveso III are also workplaces under the definition of Directive 89/654/EEC [15].

#### *2.4. Installation*

Directive Seveso III defines 'installation' as a technical unit within an establishment and whether at or below ground level, in which dangerous substances are produced, used, handled or stored; it includes all the equipment, structures, pipework, machinery, tools, private railway sidings, docks, unloading quays serving the installation, jetties, warehouses or similar structures, floating or otherwise, necessary for the operation of that installation.

Also, Directive 2009/104/EC defines 'work equipment' as follows: any machine, apparatus, tool or installation used at work [16]. Installations considered to be work equipment are for example: surface treatment installations, painting installations, installations composed of a combination of machines that work interdependently, etc. [38]. As for general service or protection installations, such as electrical installations, gas or fire protection, annexed to the workplace, that are considered as an integral part thereof, then Directive 89/654/EEC on workplaces is applicable [38].

As a result, the concept of installation, as defined by Directive Seveso III, may be considered to be part of the scope of Directive 2009/104/EC on work equipment [16], as well as Directive 89/654/EEC on the workplace [15]. More specifically, Directive 98/24/EC [7] indicates that work equipment and protective systems provided by the employer for the protection of workers shall comply with the relevant EU provisions on design, manufacture and supply with respect to health and safety. Likewise, the employer shall take measures to provide sufficient control of plant, equipment and machinery or provision of explosion suppression equipment or explosion pressure relief arrangements.

Furthermore, Directive 98/24/EC [7] specifically points out the need to adopt measures in view of explosions linked to work equipment and installations. Thus, a direct link is established between Directive 99/92/EC [28] where 'explosive atmosphere' means a mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapours, mists or dust in which, after ignition has occurred, combustion spreads to the entire unburned mixture. However, for example this directive shall not apply to the manufacture, handling, use, storage and transport of explosives or chemically unstable substances.

### **3. Comparative Analysis between Management Systems Derived from the Framework Directive and Directive Seveso III**

Directive Seveso III indicates that member states shall require the operator to draw up a document in writing setting out the major-accident prevention policy (MAPP) and to ensure that it is properly implemented. The MAPP shall be implemented by appropriate means, structures and by a safety management system, in accordance with Annex III of this directive, and it will be proportionate to the major-accident hazards, and the complexity of the organization or the activities of the establishment. Table 4 shows the structure of the safety management system according to such Annex III. This Annex III is linked, in turn, to Annex II regarding minimum data and information to be considered in the safety report referred to in Article 10 of Directive Seveso III.


betweenstructuresofriskDirectiveSevesoIII,FrameworkDirectiveandISO45001:2018

The Framework Directive does not explicitly develop a safety management system. However, it contains general principles concerning the prevention of occupational risks, the protection of safety and health, the elimination of risk and accident factors, the informing, consultation, balanced participation in accordance with national laws and/ or practices and training of workers and their representatives, as well as general guidelines for the implementation of the said principles.

In themselves, the aforementioned general principles form the basis for a management system; in this case, a system to manage the safety and health of workers. To develop this, each member state of the European Union must transpose the Framework Directive into their national legal systems.

By way of example, Law 31/1995 on occupational risk prevention transposes the Framework Directive into Spanish law [39]. This Law explicitly states that occupational risk prevention must be integrated into an undertaking's general management system, across all of the activities and across the hierarchy thereof, by means of implementing and putting into practice an occupational risk prevention plan. This occupational risk prevention plan should include the organisational structure, responsibility, roles, practices, procedures, processes and resources necessary to carry out risk prevention activity in the undertaking. The management and implementation instruments that are essential to the risk prevention plan are: the assessment of occupational risk and the planning of preventive action.

Also, Royal Decree 39/1997, which validates the Regulation on Prevention Services, develops those aspects that make it possible to integrate occupational risk prevention management into the undertaking's activities and across the hierarchical levels thereof, based on a plan that includes work techniques, organisation and conditions [40]. Thus, as shown in Table 4, correspondence may be established between the structure of the Framework Directive and the management system included in Annex III of Directive Seveso III.

Correspondence may be classified as strong, weak or non-existent. Correspondence is strong when an issue in Annex III has its direct equivalence (major risk management vs. occupational risk management) with one or more articles of the Framework Directive. Correspondence is weak when an issue only has partial equivalence. And, obviously, correspondence is non-existent whet there is no equivalence.

Considering this, there is strong correspondence in regard to the following sections of Annex III: (i) Organization and personnel, (ii) Identification and evaluation of major hazards, (iv) Management of change, and (v) Planning for emergencies.

Correspondence is weak in sections (iii) Operational control and (vi) Monitoring performance. In regard to section (iii), the Framework Directive does not explicitly state: the management and control of risks associated with ageing equipment installed in the establishment and corrosion. In regard to section (vi), the Framework Directive does not explicitly state: the adoption and implementation of procedures for the ongoing assessment of compliance with the objectives set by the operator's MAPP and safety management system; near misses. There is no (explicit) correspondence in regard to section (vii) regarding Audit and review.

Furthermore, the Framework Directive contains specific guidelines in regard to chemical agents. These guidelines may be understood in terms of the relevance of the risk of such agents on occupational risk overall. Specifically, article 6.2 of the directive states as one of the general principals of preventive activity: replacing the dangerous by the non-dangerous or the less dangerous. Also, article 6.3.a: evaluate the risks to the safety and health of workers, inter alia in the choice of work equipment, the chemical substances or preparations used, and the fitting-out of workplaces. In order to carry out such assessment regarding chemical substances, Directive 98/24/EC [7] and Directive 2004/37/EC [6], on chemical agents and on carcinogens and mutagens at work, respectively, are essential.

Considering that these directives are part of the development of the Framework Directive, they share with it the general principles of risk management. As a result, the minimum provisions for the protection of workers contained in each directive must be managed under the said general management principles. Thus, a correspondence may be observed between the said principles and provisions, from the general to the specific.

Such correspondence makes it possible, in turn, to relate the sections of Annex III of Directive Seveso III with the specific provisions of each directive. This correspondence with the aforementioned directives may be seen in Table 5. The level of detail is lower than that found in Table 4, as in this case, the aim is to offer a global overview of the common thread described, from the general (Table 4) to the specific (Table 5).

**Table 5.** Correspondence between structures of risk management systems of Directive Seveso III, Directive 98/24/CE on chemical agents and Directive 2004/37/EC on carcinogens or mutagens.


Thus, comparing the results of Tables 4 and 5 offers the following main learnings: (a) section (i) Organization and personnel of Directive Seveso III corresponds closely with the Framework Directive, while this correspondence is weaker with the individual directives analysed, limited mainly to training requirements; (b) section (ii) to (vi) of Directive Seveso III correspond closely with the individual directives. This correspondence is the result of going from the general in the Framework Directive to the specific on issues regarding chemical agents and carcinogens and mutagens pursuant to Directive 98/24/EC [7] and Directive 2004/37/EC [20], respectively; (c) in regard to section (vii) on Audit and review, which has no correspondence with the Framework Directive, reviewing the risk assessment whenever necessary is explicitly considered, such as when working conditions change, new scientific knowledge is achieved on the effects of chemical agents or limit values, etc.

### **4. Comparative Analysis between Management Systems Derived from the ISO 45001:2018 Standard and Directive Seveso III**

Implementing an OSH management system conforming to the ISO 45001:2018 standard enables an organization to manage its OSH risks and improve its OSH performance [14]. According to this voluntary standard, an OSH management system can assist an organization to fulfil its legal and other requirements. The implementation and maintenance of an OSH management system, its effectiveness and its ability to achieve its intended outcomes are dependent on a number of key factors which can include the integration of the OSH management system into the organization's business processes and compliance with its legal and other requirements.

As indicated by the ISO 45001:2018 standard, its adoption in a given organization, however, will not in itself guarantee prevention of work-related injury and ill health to workers, provision of safe and healthy workplaces and improvement of OSH performance [14]. So, in the context of this work, that is from the perspective of a risk management system, the adoption or implementation of the ISO 45001:2018 standard [14] may be understood as a tool that may assist an organisation in complying with the Framework Directive and Directive Seveso III.

As with the previous section, which carried out a comparative analysis between management systems derived from the Framework Directive and Directive Seveso III, this section contains a similar analysis, using the same criteria, comparing between management systems derived from the ISO 45001:2018 standard [14] and Directive Seveso III.

Hence, as Table 5 also shows, correspondence may be established between the structure of the ISO 45001:2018 standard [14] and the management system included in Annex III of Directive Seveso III. Consequently, the result obtained makes it possible to establish a similar correspondence between the said standard and the Framework Directive, since Directive Seveso III works as a common denominator.

The results from such analysis establish a strong correspondence with all sections from Annex III except with section (iii) Operational control, where aspects related to management and control of the risks associated with ageing equipment installed in the establishment and corrosion are not explicitly stated by the ISO 45001:2018 standard [14]. This is also true in regard to the Framework Directive, Directive 98/24/CE on chemical agents [7] and Directive 2004/37/EC on carcinogens or mutagens [20].

As a result of this correspondence, the ISO 45001:2018 standard [14] is linked closely, not only to Directive Seveso III but also to the Framework Directive and its individual directives, especially Directive 98/24/EC [7] and Directive 2004/37/EC [20], on chemical agents and carcinogens or mutagens at work, respectively.

On the other hand, the OSH management system approach defined by the ISO 45001:2018 standard [14] is founded on the concept of Plan-Do-Check-Act (PDCA). This standard indicates that it can be applied to a management system and to each of its individual elements, as follows:


The ISO 45001:2018 standard incorporates the PDCA concept into a new framework [14]. This framework can be integrated with the framework defined by Seveso III, considering the results shown in Table 4. The result of such integration is shown in Figure 2.

**Figure 2.** Integration of the Plan-Do-Check-Act (PDCA) framework defined by the ISO 45001:2018 standard [14] with the management system derived from Directive Seveso III [8].

### **5. Analysis of Transitional Spaces Between the Risk Management of Hazardous Materials in Manufacturing Processes**

An analysis is carried out below of the main transitional spaces that arise from the results obtained in the previous sections. Each of these transitional spaces may be understood as the intersection between the correspondences identified between the different sets analysed: that is, the legal context and management systems derived from Directive Seveso III, the Framework Directive and the ISO 45001:2018 standard [14].

#### *5.1. Legal Context*

As a result of the analysis carried out in the legal context section, Figure 3 shows the main correspondence observed between the directives studied; that is, between Directive Seveso III and the individual directives within the meaning of Article 16 (1) of the Framework Directive.

To show these links summarily, the same thread has been followed that configures the structure of the legal context section. To this end, the basic outline of a general manufacturing process has been considered, involving chemical agents (Directive 98/24/EC [7] and Directive 2004/37/EC [20]). Thus, this manufacturing process may take place in one or more workplaces (Directive 89/654/EEC [15]) where, among other chemical risks, there may be the risk of explosion (Directive 99/92/EC [28]). Such workplaces may be considered as establishments with installations in the scope of implementation of Directive Seveso III, other types of establishments (not falling within Directive Seveso III) or other types of workplaces. In all cases, these workplaces will have installations and work equipment (Directive 2009/104/EC [16]) that will configure the corresponding manufacturing process.

**Figure 3.** Main links formed between the individual directives (Framework Directive [6]) and Directive Seveso III [8] within the general structure of a manufacturing process.

Analysis of directives related to the safety and health of persons other than the individual directives within the meaning of Article 16 (1) of the Framework Directive, are not within the remit of this study. However, it should be pointed out that there may be connections to other regulations, such as the REACH Regulation [2] and CLP Regulation [3], or Directive 2006/42/EC on machinery [41]. These examples may be considered as fundamental regulations in the field of safety and health.

The main transitional spaces between these links, as shown in Figure 3, are describe below, considering in this regard the intersections between Directive Seveso III and the individual directives within the meaning of Article 16 (1) of the Framework Directive:


### *5.2. Management Systems*

The four transitional spaces (TS) represented conceptually in Figure 4 are derived from the results obtained in the two comparative analyses carried out between risk management systems (the links shown in Tables 4 and 5): that is, between Directive Seveso III and the Framework Directive, and between Directive Seveso III and the ISO 45001:2018 standard [14].

Transitional space TS 1 is configured by the correspondence that exists between the structure of the Framework Directive and the management systems derived from Directive Seveso III. Similarly, TS 2 is configured by the correspondence that exists between the structure of the ISO 45001:2018 standard and the management system derived from Directive Seveso III.

Transitional space TS 3 may be considered a 'natural space' between the Framework Directive and the ISO 45001:2018 standard [14] since the goal of both systems is to manage safety and health at work. However, studying this transitional space falls outside the aim of this study as such a study would form part of an analysis process regarding the implementation of the ISO 45001:2018 standard [14] by an organisation.

In any case, given that the result of implementing the ISO 45001:2018 standard [14] may be understood as a tool that can help an organisation to meet such legal requirements as complying with the Framework Directive and Directive Seveso III, the three systems may share an intersectional space, giving rise to transitional space TS 4.

Additionally, given that the provisions of Directive 98/24/EC on chemical agents [7] and Directive 2004/37/EC on carcinogens or mutagens at work [20] are in line with the general management guidelines set by the Framework Directive, the correspondence between these directives and Annex III of Directive Seveso III has been studied and the results are collected in Table 5.

The said results may be considered as a specific correspondence transferred from transitional space TS 1 to transitional space TS 4 when the intersection of the three systems takes place. Thus, TS 4 may be considered to include, at least, the provisions of Directive 98/24/EC [7] and Directive 2004/37/EC [20]. In other words, transitional space TS 4 may be considered to be a specific transitional space resulting from the intersection of three general transitional spaces.

Even if this specific transitional space has been studied in regard to the aforementioned directives, it should be pointed out that other directives, from those considered in Table 1, may also be of interest.

**Figure 4.** Transitional spaces between the following management systems: Directive Seveso III [8], Framework Directive [7] and ISO 45001:2018 standard [14].

#### **6. Discussion**

There are signs of a revitalizing interest in foundational issues in risk assessment and management, which is welcome and necessary for meeting the challenges currently faced by the field of risk. These are related to societal problems and complex technological and emerging risks [42] which can exist in manufacturing processes alongside traditional risks [43].

The second European Survey of Enterprises on New and Emerging Risks reveals that dangerous substances (or biological substances) are most prevalent in the European Union in certain sectors such as manufacturing (51.7%) [44]. As a result, new challenges for the management of dangerous substances in the workplace are emerging, for example, in the area of green jobs (bio-energy production, new types of energy storage) and in relation to the use of innovative materials (e.g. nanomaterials) and

technologies with currently unknown health risks (such as 3D printing) and substances recognised as endocrine disrupters [45].

In this context, Brocal et al. [46] considered that the relationship between the prevention of occupational accidents and major accidents is especially important. Based on this integrative perspective, Zio [47] points out to the realization that, to manage risk in a systematic and effective way, it is necessary to consider all phases of potential accident scenarios together.

There is a general research focus on dynamic risk assessment and management rather that static or traditional risk assessment [42], which can consider the dynamic evolution of conditions, both internal and external to the system, affecting risk assessment [48]. The effectiveness in the application of a dynamic risk management framework in collecting and considering evidence of emerging risks relies on the continuous development of dynamic techniques for hazard identification and risk assessment, joined with a proper safety culture [49].

However, this study does not distinguish between the risk management of both types of risks; that is, between traditional risk and emerging risk. This is due to the general characteristics of the legal and standardised context in which this study has been carried out, towards meeting the main objective set out.

In any case, this objective may be extended in future research in the direction of emerging risk management. In this regard, the CWA 16649:2013 standard on managing emerging technology-related risks may be considered to be a reference management system [50]. Such a direction may be justified, among others, by considering the data in Figure 1, which shows that the number of chemical substances used in manufacturing processes has increased in the past few years. Furthermore, by considering the hypothesis that, in general, such substances are a source of risk, implementing the TICHNER (Technique to Identify and CHaracterize NERs) technique developed by Brocal et al. [51], it could be stated that the situation described in manufacturing processes could constitute an emerging risk.

### *6.1. Major Accident and Occupational Accident*

In regard to the definitions for 'accident' considered in this study, 'major accident' is defined by Directive Seveso III, while 'occupational accident' is not defined by the directives studied. Therefore, other sources are required. Besserman and Mentzer [12] consider that each country defines their statistics differently including different definitions for lost time incidents, non-fatal injuries, and what constitutes the manufacturing/chemical industry, among others. Furthermore, such authors indicate that there is minimal reporting of true process safety metrics resulting from the loss of containment of a hazardous substance.

In any case, a major accident can also be considered to be an occupational accident if harm to workers exists. Inversely, an occupational accident can also be a major accident when it meets the requirements set out in Directive Seveso III. The causality relationship between both types of accident has not been studied here, although its interest in the sphere of safety is evident. In the 1970s, the effect of human actions and organizational factors on accident occurrence was recognized, but it took until the mid- 1980s before management became aware that they were key to achieving a good level of both occupational and process safety [52]. The incorporation of Bayesian networks into risk assessment may be another interesting focus for both research and industrial purposes, because it allows a systemic approach considering human error and management influences [49].

#### *6.2. Links and Transitional Spaces*

The main correspondence between risk management in both types of accidents is the presence in the manufacturing process of one or more of the hazardous substances included in Annex I of Directive Seveso III, for which directives derived from the Framework Directive are also applicable. The said directives may be understood as the deployment of this correspondence into further links that are more specific, giving rise to two types of transitional spaces: functional transitional spaces and regulatory transitional spaces.

Functional transitional spaces (that is, activities involving chemical agents, workplaces and installations) are interconnected as briefly outlined in Figure 3. Such interconnection must be understood as a basic outline that can be extended in different directions in the field of risk management as, for instance: the safety change management studied by Gerbec [53]; management of exposure to nanomaterials studied by Hunt et al. [54]; machine safety, which can be generally defined through Directive 2006/42/EC and the ISO 12100: 2010 and ISO/TR 14121-1: 2012 standards on safety of machinery [55,56]

As regarding regulatory transitional spaces, they are defined by the intersections between the risks management systems studied through the Framework Directive, Directive Seveso III and the ISO 45001:2018 standard.

The links shown in Table 4 between management systems derived from the Framework Directive and Directive Seveso III, have been classified as: four are strong (Annex III sections (i), (ii), (iv) and (v)), two are weak (Annex III sections: ((iii) and (vi)), and one is non-existent (Annex III section (vii)).

This result is coherent under the perspective of the Framework Directive, which compiles a set of general guidelines that are further developed by specific directives, as shown in the results in Table 5. Therefore, the set established by the Framework Directive and individual directives completes and strengthens the seven links above, configuring the transitional space TS 1.

As regards the correspondence between management systems derived from the ISO 45001:2018 standard and Directive Seveso III, shown also in Table 4, 6 of these links have been classified as strong and one as relatively strong (sections Annex III: (iii)), configuring transitional space TS 2.

These results are also coherent with the aim of an OSH management system as defined by the ISO 45001:2018 standard. Moreover, these results make it possible to draw up a coherent correspondence between the structures of the ISO 45001:2018 standard [14] and the Framework Directive, configuring transitional space TS 3.

As regards TS 4, given that it may be considered to be a specific transitional space resulting from the intersection of three general transitional spaces, it is key to defining and channelling the transitions between systems by means of the corresponding individual directives in each case, including at least Directive 98/24/EC on chemical agents [7]. This consideration is still valid when the intersection occurs between two systems, and the linking and transitional role played by the individual directives is equally important.

The risk assessment techniques are a key structuring element between the functional and regulatory transition spaces, as shown in the results of Table 4 and, especially, of Table 5. However, according to Brocal et al. [9] it is necessary to deepen through future research on the analysis of differentiating and applicative criteria between the techniques used in the field of safety occupational and safety linked to major accidents.

These links and transitional spaces may facilitate system integration. In this regard, Li and Guldenmund [13] point out that according to the literature, an integrated management system is more advanced than independent safety systems, as safety is just one of the comprehensive organization management objectives.

In the process of integrating systems, besides the existence of transitional spaces, non-traditional spaces also exist as a result of the specific aspects of each system that have no direct correlation with the other systems. These non-transitional spaces have not been studied here, yet may be equally important in any integration process, since they define the frontiers necessary to avoid unwanted interference with the transitional spaces.

#### **7. Conclusions**

The main objective of this study has been met through identifying and analysing the links and transitional spaces between the risk management of occupational accidents and major accidents that involve hazardous substances in manufacturing processes. To this end, the risk management systems derived from Directive Seveso III, the Framework Directive and the ISO 45001:2018 standard [14] have been analysed, obtaining three main results.

The first result of this analysis, the main link identified between the risk management of both types of accidents, is the presence in a manufacturing process of any of the hazardous substances included in Annex I of Directive Seveso III, for which the directives derived from the Framework Directive are also applicable, and the principles and guidelines of the ISO 45001:2018 standard are applicable on a voluntary basis [14].

As a second result, the intersection of Directive Seveso III, the Framework Directive and the ISO 45001:2018 standard, configures three general transitional spaces (TS 1, TS 2 and TS 3).

In turn, and as a third result, the intersection of these three general transitional spaces configures a specific transitional space (TS 4), which is key to defining and channelling the transition between systems by means of the individual directives that may correspond in each case, which will, at least, include the directive on chemical substances. This will enable integration processes between the systems considered.

The above results are limited from a regulatory and technical perspective. In regard to the regulatory perspective, the context is limited to the EU, as well as Directive Seveso III, the Framework Directive and any individual directives that further develop it. Other directives and regulations that are especially relevant in the sphere of safety, as for instance the REACH Regulation [2] and CLP Regulation [3], are open to further analysis to enable their integration into the management systems. From a technical perspective, no distinction has been made between traditional risk management and emerging risk management. Similarly, no distinction has been made between static and dynamic approaches.

The results and limitations stated above may point towards future paths of research, from which models to integrate the risk management of occupational accidents and major accidents may be developed based on real experiences and data.

By way of final conclusion, the identification and analysis of the links and transitional spaces carried out by this study aspire to being a starting point that will inspire other researchers to continue and further develop this study with the end goal of efficiently integrating risk management systems related to accidents derived from dangerous substances in manufacturing processes.

**Author Contributions:** Conceptualization, F.B., C.G. and M.A.S.; Investigation, F.B., C.G. and M.A.S; Methodology, F.B., C.G.; Supervision, F.B, C.G., M.A.S., G.R. and V.C.; Writing—original draft, F.B., C.G. and M.A.S.; Writing—review and editing, F.B, C.G., M.A.S., G.R. and V.C.

**Funding:** This research was funded by the Ministry of Economy and Competitiveness of Spain, title: 'Analysis and Assessment of technological requirements for the design of a New Emerging Risks standardized management SYStem (A2NERSYS)' with reference DPI2016-79824-R.

**Conflicts of Interest:** The authors declare no conflict of interest.

#### **References**


56. *ISO/TR 14121-2. Preview Safety of Machinery–Risk Assessment–Part 2: Practical Guidance and Examples of Methods*; International Organization for Standardization (ISO): Geneva, Switzerland, 2012.

© 2018 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
